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Personalized Dietary Management in Type 2 Diabetes

NCT05046886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2026-05-06

No results posted yet for this study

Summary

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

Conditions

Interventions

BEHAVIORAL

Standardized

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on macronutrient distribution.

BEHAVIORAL

Usual Care Control (UCC)

Participants are instructed to follow a Mediterranean-style diet,

BEHAVIORAL

Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from a gut microbiome-based machine learning algorithm.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Collin J Popp, PhD, RD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2025-05-22
Completion
2026-01-16

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046886 on ClinicalTrials.gov